TriangleNCT03125902 · OUTCOME
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
What was measured
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Analysis population: ITT population: all randomized participants, whether or not the assigned study treatment was received
Groups in this outcome
Placebo and Paclitaxel
Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
Atezolizumab and Paclitaxel
Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Placebo and Paclitaxel | 220 |
| Atezolizumab and Paclitaxel | 431 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo and Paclitaxel | 5.55 | Not reported | 5.36 | 6.51 | Not reported |
| Atezolizumab and Paclitaxel | 5.68 | Not reported | 5.42 | 7.16 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.05
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1343
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.05
- group Description
- Unstratified Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1285
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.05
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Stratified Analysis
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1343
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.05
- group Description
- Unstratified Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1285
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.36
- upper Limit
- 6.51
- value
- 5.55
- group Id
- OG001
- lower Limit
- 5.42
- upper Limit
- 7.16
- value
- 5.68
- denoms
- counts
- group Id
- OG000
- value
- 220
- group Id
- OG001
- value
- 431
- units
- Participants
- description
- PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Placebo and Paclitaxel
- description
- Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Atezolizumab and Paclitaxel
- param Type
- MEDIAN
- population Description
- ITT population: all randomized participants, whether or not the assigned study treatment was received
- reporting Status
- POSTED
- time Frame
- From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
- title
- Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice